Does Sildenafil Increase Exercise Performance in Air Pollution?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to examine if the ingestion of a standard dose of sildenafil enhances the athletic performance of competitive athletes when exercising in a high pollutant environment verses a low air pollutant environment.

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Detailed Description

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This study will evaluate effects of sildenafil on exercise performance while breathing high levels of emission exhaust ultrafine and fine particulate matter. Exercise performance will be measured by work accumulation (total kJ) during a 6-min maximal effort cycle ergometer ride (CER) done immediately after 30 min cycling at 75% of 6 min mean watts determined from familiarization trial. Peak oxygen consumption, cardiac output, pulmonary artery pressure, diffusion capacity(DLco), and SaO2 will be determined for each trial. Blood and urine will be analyzed for sildenafil using LC/MS.

Conditions

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Pulmonary Hypertension Pulmonary Artery Pressure Exercise Performance Air Pollution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Subjects will exercise in a high air pollutant environment after ingesting a standard dose of sildenafil.

Group Type ACTIVE_COMPARATOR

sildenafil

Intervention Type DRUG

sildenafil 50 mg ingested orally 1 hour prior to exercise testing

2

Subjects will exercise in a low pollutant environment after ingesting a standard dose of sildenafil.

Group Type ACTIVE_COMPARATOR

sildenafil

Intervention Type DRUG

sildenafil 50 mg ingested orally 1 hour prior to exercise testing

3

Subjects will exercise in a high pollutant environment after ingesting a placebo.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.

4

Subjects will exercise in a low pollutant environment after ingesting a placebo.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.

Interventions

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sildenafil

sildenafil 50 mg ingested orally 1 hour prior to exercise testing

Intervention Type DRUG

placebo

matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.

Intervention Type OTHER

Other Intervention Names

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Viagra sugar pill

Eligibility Criteria

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Inclusion Criteria

* non-asthmatic
* asthmatic
* active participants in endurance sports.

Exclusion Criteria

* history of high blood pressure
* history of heart disease
* pulmonary arterial hypertension
* pulmonary emboli
* diagnosis of moderate to severe asthma (FEV1 \<75% predicted)
* pregnant or lactating

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes